An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients with Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study

Sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Study ID
NCT05299931
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    dose escalation from every 8 weeks to every 4 weeks only in arm 2

Study Details

The aim of the study is to assess the long-term efficacy and safety of a ustekinumab 90mg subcutaneous (SC) every 4 weeks (Q4w) regimen in patients with Crohn's disease previously enrolled in the REScUE study (NCT04245215) because of secondary loss of response to a ustekinumab 90mg SC every 8 weeks (Q8w) regimen.

Key Dates

Start date
Sep 10, 2021
Status verified
Feb 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Subcutaneous (SC) ustekinumab every 8 weeks (Q8w)
    Patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm will continue ustekinumab 90 mg SC Q8w if they are "Q8w responders" at the end of REScUE Patients treated with a OLE treatment regimen of ustekinumab 90 mg SC Q8w will be able to cross-over to a OLE treatment regimen of ustekinumab 90 mg SC Q4w if they meet the criteria of CD worsening at week 12 or at any timepoint beyond week 12 after entering REScUE-OLE
  • Other: Subcutaneous (SC) ustekinumab every 4 weeks (Q4w)
    Patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm will switch to ustekinumab 90 mg SC Q4w ("Cross-over") if they are "Q8w non-responders" at the end of REScUE OR Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm will continue ustekinumab 90 mg SC Q4w if they are "Q4w responders" at the end of REScUE

Primary Outcome Measure

Proportion of patients in both treatment arms in steroid-free clinical remission [ Time Frame: Week 56 ]

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